This study is planned to prospectively evaluates the efficacy and safety of the zanubrutinib, obinutuzumab, and lenalidomide (ZGR) combination regimen in treatment-naïve follicular lymphoma (FL) patients in a Chinese population.
Gender: No restrictions; age ≥18 years.
Diagnosis: Histologically confirmed CD20-positive follicular lymphoma (FL), Grade 1, 2, or 3A, per 2016 WHO classification. All patients must provide sufficient archived or fresh tumor tissue samples for immunohistochemical (IHC) analysis.
a) Bulky disease: Lymph node or extranodal (excluding spleen) mass with maximum diameter ≥7 cm.
b) Local symptoms or organ dysfunction due to progressive lymphadenopathy or extranodal tumor mass.
Histologic evidence of central nervous system (CNS) lymphoma, leptomeningeal lymphoma, or transformation to high-grade lymphoma (e.g., diffuse large B-cell lymphoma, DLBCL).
Grade 3B follicular lymphoma (FL) or transformed FL.
Ann Arbor Stage I FL.
Prior history of malignancy, unless the patient has been disease-free for ≥5 years and the treating physician deems the risk of recurrence low (exceptions: non-melanoma skin cancer, cured localized prostate cancer, carcinoma in situ of the cervix, or squamous intraepithelial lesions on PAP smear).
Single group
Induction Therapy: Zanubrutinib, obinutuzumab, lenalidomide
DrugAll enrolled patients received: Zanubrutinib: 160 mg twice daily, orally, on Days 1-28; Obinutuzumab: 1000 mg, intravenous infusion: Days 1, 8, and 15 of Cycle 1,on Day 1 of Cycles 2-6; Lenalidomide: 25 mg once daily, orally, on Days 1-21 of each 28-day cycle.
Maintenance therapy: Zanubrutinib, lenalidomide
DrugMaintenance therapy consists of zanubrutinib plus lenalidomide: Zanubrutinib: 160 mg twice daily, orally, on Days 1-28.Lenalidomide: 25 mg every other day, orally, on Days 1-21 of each 28-day cycle
Objective response rate，ORR
Defined as the proportion of patients with complete or partial response as assessed by response to induction therapy
Complete response rate，CRR
defined as the proportion of patients with complete response as assessed by response to induction therapy.
Best overall response rate (ORR) and complete response rate (CRR) during treatment
defined as the proportion of patients with best response as assessed in the induction therapy.
CRR and ORR at end of treatment
Defined as the proportion of patients with complete response, and complete or partial response as assessed by response to the end of treatment(induction + maintenance therapy)
Progression-free survival (PFS)
The time from the enrollment of a subject to the occurrence of (in any way) progression of disease or Death for any reason. patients with indeterminate recurrence or Death at the last follow-up, defined as the date of the last Investigation
Minimal residual disease (MRD) monitoring
Circulating tumor DNA (ctDNA) analysis via next-generation sequencing (NGS)
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